HUTCHMED (China) Limited Launches Phase I/IIa Trial Of HMPL-A580 For Advanced Solid Tumors Across China And The United States After First Patient Dosed On March 4, 2026

HUTCHMED (China) Limited announced the launch of a Phase I/IIa clinical trial for HMPL-A580, the company’s second novel Antibody-Targeted Therapy Conjugate developed for patients with unresectable, advanced, or metastatic solid tumors in both China and the United States. The first patient was dosed on March 4, 2026, marking a significant step forward for the program.

HMPL-A580 is described as a first-in-class therapy, built around a highly selective PI3K/PIKK small-molecule inhibitor payload that is attached to an anti-EGFR antibody through a cleavable linker. It represents HUTCHMED’s second ATTC built on this innovative payload design. EGFR is known to be overexpressed in many solid tumors and plays a central role in driving tumor growth and progression. Preclinical research has indicated that blocking the PAM pathway can work synergistically with anti-EGFR therapy to improve anti-tumor activity. These findings will be shared in greater detail at an upcoming scientific meeting.

The newly initiated clinical trial is a first-in-human, multicenter, open-label study designed to evaluate several key aspects of HMPL-A580, including safety, tolerability, pharmacokinetics, immunogenicity, and early signals of efficacy. The trial is divided into two stages. The Phase I dose-escalation stage will explore multiple intravenous dose levels to determine the maximum tolerated dose and identify the recommended dose suitable for expansion. Once an appropriate dosing range is established, the trial will move into the Phase IIa expansion and optimization stage. 

This second stage will further assess safety and tolerability while examining the preliminary anti-tumor effects of HMPL-A580 in selected solid tumor types. The goal is to refine dosing strategy and establish the recommended regimen for subsequent development. Additional information about the study, including eligibility and trial design, is available on clinicaltrials.gov under the identifier NCT07396584.